Digital MEDIcal TWIN for the Prediction of Arrhythmic Sudden Cardiac Death After a Myocardial Infarction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Programmed ventricular stimulation, Cardiac CT scan.
- Who it may be relevant to
- Registry conditions: Sudden Cardiac Death, Myocardial Infarction. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
TWIN-SCD STEMI is a multicentric prospective, non-randomized pilot study designed to establish a multiparametric model for predicting life-threatening ventricular arrhythmias in patients experiencing their first myocardial infarction. The primary objective of the study is to develop an algorithm with superior predictive performance (sensitivity and specificity) compared to the currently used criterion for the implantation of a cardiac defibrillator, which is a left ventricular ejection fraction (LVEF) of less than 35%.
Detailed description
Sudden cardiac death (SCD) accounts for 10% of deaths in the general population, with 80% of these cases caused by malignant ventricular arrhythmias. These arrhythmias predominantly occur in individuals with cardiomyopathies, especially those with a history of myocardial infarction (MI). Currently, SCD prevention after a first MI relies on risk stratification based on myocardial contractility, specifically indicating prophylactic cardiac defibrillator implantation for patients with a left ventricular ejection fraction (LVEF) ≤ 35%. However, this approach is insufficient due to two main reasons:
1. Among patients with LVEF ≤ 35%, only a minority (2-5% per year) will experience arrhythmias and benefit from defibrillator implantation, while all face potential serious complications from the device. 2. Most SCD cases occur in patients with LVEF \> 35%. Although these patients have a lower individual arrhythmia risk (1-2% per year), they represent a substantially larger population at risk, with no stratification within this group.
Emerging evidence suggests that additional parameters (biological markers, cardiac imaging, and electrophysiologic data) can better characterize the arrhythmogenic substrate in patients after their first MI, enabling improved identification of those at risk for arrhythmic SCD.
The primary objective of this study is to develop a multiparametric model that outperforms the current criterion (LVEF \< 35%) for predicting the need for cardiac defibrillator implantation in patients presenting with a first myocardial infarction. Clinical data, biological data, imaging data of the scar using CT scan and MRI, and electrophysiological data from 12-lead ECG, 24-hour Holter ECG will be used to establish this multiparametric model. The model will be compared to the current criteria for predicting the occurrence of malignant ventricular arrhythmias (spontaneous during the one-year follow-up or induced by an electrophysiology study at 12 months and 24 months) in this cohort.
Interventions
- Procedure Programmed ventricular stimulation
Invasive cardiac electrophysiology (EP) study - Procedure Cardiac CT scan
Cardiac CT scan with contrast enhancement
Primary outcome measures
- Occurrence of sudden cardiac death or sustained ventricular arrhythmia [Time frame: From enrollment to the end of the 60-months follow-up]
Secondary outcome measures (2)
- Occurrence of syncope at M60 [Time frame: At month 60 after enrillment]
- Occurrence of non-sustained ventricular arrhythmias at M60 [Time frame: At month 60 after inclusion]
Eligibility criteria
Inclusion criteria
- History of ST-segment elevation myocardial infarction (STEMI) in the last 6 months
- Signed informed consent
- Affiliated to or beneficiary of a health insurance
Exclusion criteria
- Renal failure (Creatinine clearance <30 mL/min), or a systemic illness likely to limit survival to <1 year
- Women who are pregnant, lactating, or who are planning to become pregnant within 2 years following her inclusion
- Unable to understand the nature, risks, significance and implications of the clinical investigation or unwilling to provide written informed consent
- Participant under legal protection
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
France · 1 center
- CHU de Bordeaux, Hôpital Cardiologique du Haut-Lévêque — Pessac
Identifiers
NCT: NCT07527494 · CHUBX 2024/92